Text Size

The Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging

This study is currently recruiting participants.
Verified July 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01172041
First received: July 26, 2010
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

This study will investigate whether audiovisual biofeedback, in which visual and audio cues are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D PET scans.


Condition Intervention
Lung Cancer
 Device: Real time position management system
Device: LS PET/CT
Drug: 18-FDG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Real time position management system
    Device to monitor respiration by using optical monitoring of a marker block placed on the abdomen of the patient.
    Other Name: Varian
    Device: LS PET/CT
    PET/CT scanner for acquiring CT and PET images (3D and 4D)
    Other Name: GE
    Drug: 18-FDG
    15mCi
    Other Names:
    • Fludeoxyglucose (18F)
    • fluorodeoxyglucose (18F)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center

Criteria

Inclusion Criteria:

Required for inclusion in this study are:

  • Informed consent
  • Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center
  • Age 18 or greater
  • Painfree in supine position
  • Karnofsky performance status 50 or greater

The inclusion of educationally disadvantaged, decisionally impaired or homeless people are allowed if informed consent, in the opinion of the consenting investigator (study PI, co-PI or research nurse), is obtained.

Exclusion Criteria:

No

  • Pregnant women
  • Stanford employees
  • Stanford students
  • Prisoners will be eligible for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172041

Contacts
Contact: Paul Keall (650) 723-5549 paul.keall@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Paul Keall     650-723-5549     paul.keall@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Paul J Keall            
Sub-Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D.            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Paul J Keall Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01172041     History of Changes
Other Study ID Numbers: LUN0026, 98393, SU-05152009-2578
Study First Received: July 26, 2010
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013